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| Sponsor: | New York State Psychiatric Institute |
|---|---|
| Collaborator: |
National Institute on Drug Abuse (NIDA) |
| Information provided by: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00344565 |
Purpose
The purpose of this study is to test whether a cognitive behavioral therapy (CBT) and a medication called modafinil, which is approved to treat sleep disorders, will help individuals who are abusing cocaine.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Dependence |
Drug: Modafinil Behavioral: Cognitive Behavioral Therapy--Relapse Prevention |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Estimated Enrollment: | 30 |
Chronic cocaine abuse has been documented to produce cognitive impairments in various domains. The observed cognitive deficits in the substance abuse population include, but are not restricted to, attention, concentration, verbal and nonverbal memory, problem solving and abstract reasoning. Our recent studies (IRB Protocol # 3998) demonstrated that in cocaine dependent participants such cognitive deficits have been shown to: 1) negatively effect retention and 2) impede the ability of the drug abuser to benefit from cognitive behavioral therapy- relapse prevention (CBT-RP) that requires participant to attend to novel stimuli, integrate new information with existing stores, and translate information into behavior change (Aharonovich, Hasin & Nunes, 2003; Aharonovich et al, in press). Furthermore, the toxic effects of cocaine together with withdrawal symptoms, such as fatigue and hypersomnia make it difficult to fully engage in any psychosocial intervention including CBT-RP.
Recent findings indicate that cocaine dysregulates reward-related glutamate pathways (Dackis & O’Brien, 2003; Kalivas et al, 2003). Modafinil is a medication known to improve attention, increase wakefulness, energy, and alertness in part by increasing glutamate levels. In light of this work and the negative affect of cognitive impairments on treatment outcomes, testing cognitive enhancing medications that act on glutamate pathways is a novel promising strategy for improving treatment for cocaine dependence. Modafinil is approved for sleep disorders and is a relatively safe medication for cocaine-dependent participants as it has a low abuse potential and has shown promise in a double blind placebo controlled trial for cocaine dependence (Rush et al, 2002; Jasinski, 2000, Dackis et al, 2005). We therefore propose a double blind placebo controlled 12-week exploratory pilot study of modafinil, a “wakefulness agent,” in conjunction with sessions of CBT-RP enhanced with motivational interviewing components.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Efrat Aharonovich, PhD | 212 923 3031 |
| United States, New York | |
| Subtance Treatment & Research Services (STARS) | Recruiting |
| New York, New York, United States, 10032 | |
| Sub-Investigator: John Mariani, MD | |
| Principal Investigator: | Efrat Aharonovich, PhD | Columbia University - New York State Psychiatric Institute |
More Information
| ClinicalTrials.gov Identifier: | NCT00344565 History of Changes |
| Other Study ID Numbers: | Protocol # 5148 |
| Study First Received: | June 26, 2006 |
| Last Updated: | October 16, 2006 |
| Health Authority: | United States: Institutional Review Board |
|
Cocaine-Related Disorders Substance-Related Disorders Mental Disorders Modafinil Central Nervous System Stimulants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |